EP2533724A2 - Dispositif pour préparer et introduire un greffon ou un implant dans un corps vivant, en particulier pour des interventions ophtalmologiques - Google Patents

Dispositif pour préparer et introduire un greffon ou un implant dans un corps vivant, en particulier pour des interventions ophtalmologiques

Info

Publication number
EP2533724A2
EP2533724A2 EP11822804A EP11822804A EP2533724A2 EP 2533724 A2 EP2533724 A2 EP 2533724A2 EP 11822804 A EP11822804 A EP 11822804A EP 11822804 A EP11822804 A EP 11822804A EP 2533724 A2 EP2533724 A2 EP 2533724A2
Authority
EP
European Patent Office
Prior art keywords
opening
syringe
graft
implant
nozzle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP11822804A
Other languages
German (de)
English (en)
Other versions
EP2533724B1 (fr
Inventor
Peter Szurman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Geuder AG
Original Assignee
Geuder AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Geuder AG filed Critical Geuder AG
Priority to RS20160634A priority Critical patent/RS55066B1/sr
Publication of EP2533724A2 publication Critical patent/EP2533724A2/fr
Application granted granted Critical
Publication of EP2533724B1 publication Critical patent/EP2533724B1/fr
Priority to HRP20160972TT priority patent/HRP20160972T1/hr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1662Instruments for inserting intraocular lenses into the eye
    • A61F2/167Instruments for inserting intraocular lenses into the eye with pushable plungers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/148Implantation instruments specially adapted therefor

Definitions

  • the present invention relates to a device for providing and introducing a graft or an implant into the living body, in particular for opthalmological procedures, and in particular for performing a DMEK operation.
  • Transplantation of the human cornea is one of the most common and successful transplant surgery procedures.
  • the transplantation of the cornea using all its layers epipithelium, Bowman's membrane, stroma, Descemet's membrane and endothelial cell layer
  • epithelium epidermal growth factor
  • stroma stroma
  • Descemet's membrane and endothelial cell layer have been known for over 100 years.
  • Good results are generally obtained with this method of operation, but convalescence is very lengthy and usually a visual recovery can only be achieved after removal of the second suture. This can be up to 18 months after the procedure.
  • DMEK Descemet Membrane Endothelial Keratoplasty
  • the diseased endothelial cells, including the underlying Descemet membrane can be removed and replaced with a Descemet membrane with healthy donor endothelium of a donor.
  • a perforating keratoplasty can be dispensed with; rather, the transplant can be replaced by a comparatively small one Transfer incision into the anterior chamber of the eye and propagate it with very careful manipulation. Thereafter, the membrane preparation is fixed by adding air to the rear stroma.
  • a whole range of surgical and in particular ophthalmological procedures are known or conceivable in which a graft or an implant is provided and introduced into the living body. It is in terms of a rapid convalescence of the patient - as exemplified above with reference to the DMEK operation - advantageous to bring a transplant or implant by an incision limited, and in particular the smallest possible size in the living body.
  • the graft may already be damaged or destroyed during the provision in the device due to the inevitably small dimensions of such a device. Possibly. For example, provision of the graft in the device is initially impossible due to the small size of the device.
  • the present invention is therefore based on the object to provide a device which is suitable both for the careful provision and the exact introduction of a graft or an implant in the living body.
  • a device is initially provided, with or in which both a recording of the graft or implant and thus a provision as well as an introduction into the body of the patient can take place.
  • a suitable implant can also be provided or introduced in a manner which is obvious to a person skilled in the art. However, this is not explicitly repeated on the occasion of each individual case.
  • the graft or implant can be introduced through the first, larger opening in the device without the risk of damage - especially by wall or edge contact with the device - takes place.
  • larger opening of the device can also introduce and provide transplants, which have larger dimensions in the original state than the diameter of the incision, through which an introduction of the graft is planned in the body of the patient.
  • the device offers the possibility of introducing the graft provided within the device now through the second, smaller opening of the device in the body of the patient, namely by the smallest possible incision.
  • the section of the device associated with the second opening can accordingly be designed as a cannula-like end or connectable to a suitable cannula.
  • the portion of the device having the second, smaller opening is generally configured to permit insertion of the graft or implant into the body of the patient via the second opening.
  • a suitable graft together with surrounding liquid to be sucked through the first opening into the device by sucking liquid through the second opening or applying a negative pressure. Thereafter, the graft can be introduced through the second, smaller opening in the body of the patient by liquid supplied through the first opening or a suitable pressure is built up.
  • the cross section of the device decreases.
  • the graft can be moved particularly gently from the first opening to the second opening in order to be introduced into the patient.
  • the transition between the first and the second opening can be designed so that, for example, takes place an automatic rolling of the graft, namely in particular with respect to the transplantation of corneal layers. So a basic relief for the performing surgeon is created.
  • the device With the device, a standardization of certain interventions, for example. Of DMEK operations allows.
  • An optionally very difficult preparation of donor tissue, in particular of corneal layers, can be carried out by transplantation or cornea banks and the donor tissue can already be suitably presented in a device according to the invention to be used in the one-way procedure.
  • the surgeon can then remove as needed a pre-sterilized graft or implant within a device according to the invention from a sterile packaging and then make a transplantation intervention.
  • the surgeon would have nothing to do with the preparation and the provision of the graft.
  • the device allows the pre-sterilized delivery of grafts within the device of the invention as a disposable product. Due to the lack of preparation and the simplified introduction of the graft during the procedure inhibition thresholds as well as financial reservations of the surgeons against novel surgical methods, in particular the DMEK operation, can be reduced.
  • the invention has provided a device for gently providing and accurately introducing a graft or implant into the living body.
  • the outer edge of the second opening of the device in the nozzle of a syringe in particular a disposable syringe, and in particular a disposable syringe with 5 ml volume inserted, and / or is the first opening of the device the nozzle of a syringe, in particular a disposable syringe, and in particular a disposable syringe with 5 ml volume, attachable.
  • a particularly simple and standardized deployable device is specified.
  • the outer edge of the second opening can be designed so that it can be inserted into the nozzle of a known disposable syringe.
  • the graft (including fluid) can be drawn through the first opening into the device by pulling the plunger of the syringe connected to the second port backwards.
  • the first, larger opening may be attachable to the nozzle of such a conventional syringe.
  • the graft provided within the device can be introduced into the body of the patient during the procedure by fitting the first opening onto the nozzle of a syringe and forcing liquid into the device by actuating the plunger of the syringe.
  • liquid present in the interior of the device can be conveyed together with the graft through a suitable incision into the body of the patient.
  • provision and introduction of a graft can take place virtually immediately after one another.
  • the trans- implanted via a plugged onto the second opening of the device syringe through the first opening in the device.
  • the syringe is then removed from the second end and now inserted into the first opening.
  • the graft can then be introduced into the body of the patient as intended.
  • outer edge or the outer diameter of the second opening can also be referred to as a narrow end of the device, and the first opening can also be referred to as the inner diameter of the wide end of the device.
  • the terms used above are not intended to be limiting in this respect.
  • the first opening has an inner diameter of approximately 5 mm and / or the second opening has an outer diameter of approximately 1.75 mm.
  • the openings in the manner described above are suitable to be connected to a commercial disposable syringe with 5 ml volume.
  • the device has a conical section-in particular a central one-and / or the first opening is formed in a possibly cylindrical first section of the device and / or the second opening is in a slightly conical or cylindrical second section of the device educated.
  • a gentle provision and introduction of a graft or implant it is particularly expedient to implement the cross-sectional reduction of the device between the first and the second opening at least in sections by means of a conical course of the inner wall.
  • the graft can be promoted without damage from the first to the second opening.
  • a steady reduction in cross-section can bring about scheduled collapse or folding of the graft.
  • the first opening is formed in a cylindrical section of the device is.
  • the second opening may be formed in a slightly conical or cylindrical portion of the device. Via a cylindrical section, the second opening can be inserted without play into the nozzle of a syringe.
  • the insertion process into the nozzle and in particular the introduction of a graft into the body of the patient with a slightly conical formation of this section is facilitated. Furthermore, this can result in a defined, circumferential sealing line between the outer surface of this section and the outlet opening of the nozzle of a syringe.
  • the device may have a total length of about 4 mm, in particular wherein a portion associated with the first opening a Length of about 1 mm and / or a central portion has a length of about 2 mm and / or a second opening associated portion has a length of about 1 mm.
  • the device according to the invention is made of plastic, in particular of transparent plastic, or of metal.
  • the device according to the invention can be made in particular of plastic material, as it is also used for commercial disposable syringes. Such materials can be provided inexpensively and are effectively sterilized from the factory.
  • the choice of a transparent plastic has the advantage that the position of the graft / implant can be observed within the device.
  • the manufacture of the metal device according to the invention would have the advantage of greater robustness and reusability. For this, a metal device could be easily sterilized by the user by heating.
  • the device has an adhesion-inhibiting substance, in particular heparin, on the inside.
  • adhesion-inhibiting substance in particular heparin
  • a ready-to-use set according to the invention comprises a device according to the invention in a sterile packaging.
  • the surgeon can provide a ready-to-use device for performing a planned surgical intervention.
  • the device may be treated by a conventional sterilization method, for example by radiation sterilization.
  • the device according to the invention like a disposable syringe or a disposable cannula, can be removed from the packaging in a sterile condition and used directly as a disposable product for surgical intervention.
  • the device according to the invention offers all the advantages which have already been described above. Reference is therefore made to these above remarks to avoid repetition.
  • the ready-to-use set according to the invention can contain any of the advantageous embodiments and refinements of the device according to the invention described in detail above, whereby the advantages already described are again obtained.
  • the set additionally has a syringe, and / or the device already contains a graft or an implant within the set.
  • the set may already have a particularly suitable disposable syringe, in particular with a volume of 5 ml, with which the device can be operated.
  • the second opening of the device may already be inserted into the nozzle of the contained syringe.
  • a single sterile package may include both a device of the invention and a disposable syringe adapted thereto, both components of the kit being provided sterilized.
  • the ready-to-use set can contain a device according to the invention which already contains a graft or an implant.
  • the device can already contain the graft to be grafted as a "preloaded" product,
  • a product can be provided within the set of specialized providers, for example corneal banks or implant manufacturers, in a sterile and immediately usable state within a device according to the invention. Accordingly, the surgeon himself does not have to worry either about the preparation of the tissue or the preparation of the tissue / implant or sterilization
  • a device according to the invention as a preloaded product can already be provided with the first opening connected to a disposable syringe within the ready-to-use set be filled with device and syringe with a suitable liquid. The device then only needs to be removed from the sterile packaging, by actuating the syringe already connected to the device, the graft or the implant can then be introduced directly into the patient's body through an incision.
  • FIG. 1 is a side sectional view of a preferred embodiment of the device according to the invention, wherein in the lower part of the figure, the narrow end of the device with the second opening is shown again separately and rotated by 90 °,
  • FIG. 2 shows, in a schematic sequence, the use of the device according to the invention in conjunction with a commercially available device. - lo
  • a disposable syringe to provide an implant, here corneal layers for a DMEK operation, within the device, and
  • FIG. 1 shows at the top a side sectional view of a preferred exemplary embodiment of the device according to the invention, which is designed here as a cartridge 1.
  • This cartridge 1 is made in the present example of transparent plastic, as it is used, for example. For the production of conventional disposable syringes.
  • the device according to the invention has two opposite, end-side openings 2, 3.
  • the first opening 2 has a larger diameter than the second opening 3.
  • the structure of the device according to the invention in the form of the cartridge 1 can be divided into three longitudinally divided sections 4, 5, 6.
  • a first section 4 is associated with the first opening 2.
  • This section has a cylindrical outer wall. The inner surface of this first portion 4 tapers slightly over the length of the device.
  • the first section 4 can be plugged tightly and without play on the nozzle of a syringe.
  • the central portion 5 of the cartridge 1 tapers both outwardly and inwardly to provide a transition from the first opening 2 to the second opening 3. Due to the conical configuration of this section 5, an implant or transplant can be transported without damage from the first opening 2 to the second opening 3 (in particular where the device is filled with a suitable liquid) and also within the device.
  • the second section 6 which is assigned to the second opening 3 of the device, tapers slightly on the outside, in order in the region of the second opening 3 to insert the device into the smallest possible incision in the body of the device. to relieve patients.
  • On the inside of this section 6 is cylindrical in the embodiment shown.
  • the narrow end of the device with the second opening 3 is again shown separately and rotated by 90 ° in a sectional view.
  • the plane formed by the second opening 3 differs significantly from a perpendicular to the longitudinal axis of the device.
  • the tip thus created at the front, upper end of the second opening 3 facilitates insertion into an incision in the body of the patient.
  • the passage area for the graft or the implant from the second opening 3 is increased, although the inner diameter of the second opening 3 seen perpendicular to the longitudinal axis of the device is very small.
  • the second portion 6 of the device is sized to be inserted into the nozzle of a disposable syringe to force the graft or implant through the first opening 2 by actuation of a syringe (not shown) connected to the second port 3 to suck in the interior of the device.
  • the first opening 2 can be plugged onto the nozzle of a disposable syringe.
  • the first opening 2 has an inner diameter of approximately 5 mm
  • the second opening 3 has an outer diameter (viewed perpendicular to the longitudinal axis) of approximately 1.75 mm.
  • FIG. 2 shows in a schematic sequence (shown from top to bottom), the use of the device according to the invention, namely the cartridge 1, in conjunction with a commercially available syringe 7, in particular a commercially available disposable syringe.
  • a graft 8 namely donor tissue from corneal layers for a DMEK intervention used.
  • this is the Descemet membrane with the endothelium.
  • any other suitable donor tissue or implant can be provided within the device according to the invention.
  • the cartridge 1 is connected to the second opening 3, i. with the second portion 6, in the nozzle 9 of the syringe 7 inserted (top view). In this case, between the second portion 6 and the nozzle 9, a tight fit with sufficient tightness is achieved.
  • the graft 8 is drawn under liquid or with the addition of liquid in the device according to the invention (second view from above).
  • the graft 8 is provided in the middle of the kartsearch 1 due to a further development of the syringe 7, namely in the region of the central section 5.
  • FIG. 3 also shows in a schematic sequence (from top to bottom) the further use of the device according to the invention together with the syringe 7 for introducing the graft 8 into the body of the patient, namely into an incision. sion 1 1 in the eye 12 of the patient to perform a DMEK operation.
  • the cartridge 1 with the provided graft 8 with the larger, first opening 2 has been connected to the nozzle 9 of the syringe 7.
  • the device according to the invention is ready for insertion of the graft 8 in the body of the patient.
  • the graft 8 After insertion of the graft 8 in the eye 12, namely in the anterior chamber, this can be spread out in a suitable manner by very careful manipulation. Thereafter, the graft 8 can be fixed by means of air addition to the rear stroma.
  • the cartridge 1 together with the syringe 7 is withdrawn from the incision 1 1 (lowest illustration of FIG. 3).
  • the incision 1 1 can then - if necessary - provide adequate aftercare.
  • the cartridge 1 and the syringe 7 are discarded after the procedure.

Landscapes

  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif pour préparer et introduire un greffon (8) ou un implant dans un corps vivant, en particulier pour des interventions ophtalmologiques, en particulier pour effectuer une opération de kératoplastie endothéliale de la membrane de Descemet (DMEK), comprend une cartouche (1) ou une enveloppe comportant deux ouvertures terminales opposées (2, 3), la première ouverture (2) présentant un diamètre supérieur à celui de la deuxième ouverture (3). Le dispositif selon l'invention est conçu son seulement pour préparer avec ménagement mais aussi introduire avec précaution un greffon (8) ou un implant dans un corps vivant. Cette invention concerne en outre un ensemble prêt à l'emploi qui comporte ledit dispositif.
EP11822804.8A 2010-11-17 2011-11-17 Dispositif pour préparer et introduire un greffon ou un implant dans un corps vivant, en particulier pour des interventions ophtalmologiques Active EP2533724B1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
RS20160634A RS55066B1 (sr) 2010-11-17 2011-11-17 Uređaj za pripremu i uvođenje transplantata ili implantata u živi organizam, posebno kod oftalmoloških intervencija
HRP20160972TT HRP20160972T1 (hr) 2010-11-17 2016-07-29 Uređaj za pripremu i uvođenje transplantata ili implantata u živo tijelo, posebno za oftalmološke zahvate

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE201010051458 DE102010051458B4 (de) 2010-11-17 2010-11-17 Vorrichtung zum Bereitstellen und zum Einbringen eines Transplantats oder eines Implantats in den lebenden Körper, insbesondere für ophthalmologische Eingriffe und gebrauchsfertiges Set umfassend diese Vorrichtung.
PCT/DE2011/050048 WO2012065602A2 (fr) 2010-11-17 2011-11-17 Dispositif pour préparer et introduire un greffon ou un implant dans un corps vivant, en particulier pour des interventions ophtalmologiques

Publications (2)

Publication Number Publication Date
EP2533724A2 true EP2533724A2 (fr) 2012-12-19
EP2533724B1 EP2533724B1 (fr) 2016-05-11

Family

ID=45347561

Family Applications (1)

Application Number Title Priority Date Filing Date
EP11822804.8A Active EP2533724B1 (fr) 2010-11-17 2011-11-17 Dispositif pour préparer et introduire un greffon ou un implant dans un corps vivant, en particulier pour des interventions ophtalmologiques

Country Status (10)

Country Link
EP (1) EP2533724B1 (fr)
DE (2) DE102010051458B4 (fr)
DK (1) DK2533724T3 (fr)
ES (1) ES2585634T3 (fr)
HR (1) HRP20160972T1 (fr)
HU (1) HUE028091T2 (fr)
PL (1) PL2533724T3 (fr)
PT (1) PT2533724T (fr)
RS (1) RS55066B1 (fr)
WO (1) WO2012065602A2 (fr)

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US10481051B2 (en) 2016-10-13 2019-11-19 Lions VisionGift Corneal tissue sample assemblies and related methods of use

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DE102010051458B4 (de) 2010-11-17 2013-05-23 Geuder Ag Vorrichtung zum Bereitstellen und zum Einbringen eines Transplantats oder eines Implantats in den lebenden Körper, insbesondere für ophthalmologische Eingriffe und gebrauchsfertiges Set umfassend diese Vorrichtung.
DE112014007251A5 (de) * 2014-12-15 2017-09-14 Geuder Ag Vorrichtung zur lagerung und zum transport eines transplantats oder implantats
DE102016007738A1 (de) 2016-06-27 2017-12-28 Universität Zu Köln Vorrichtung zur Transplantation einer Descemet-Membran
DE102016220155A1 (de) 2016-10-14 2018-04-19 Geuder Ag Entfaltungskanüle
CN109481083B (zh) 2017-09-11 2021-06-01 财团法人工业技术研究院 植入器械
DE102018209194B4 (de) 2018-06-08 2020-01-02 Geuder Ag Vorrichtung zum Bereitstellen und zum Einbringen eines Transplantats oder Implantats in einen menschlichen oder tierischen Körper und gebrauchsfertiges Set umfassend diese Vorrichtung
US11992435B2 (en) 2018-12-27 2024-05-28 Lions World Vision Institute, Inc. Needle injector and carrier for DMEK and PDEK grafts
WO2020176818A1 (fr) * 2019-02-28 2020-09-03 Tissuecor, Llc Injecteur de tissu de greffe
US10806558B1 (en) 2019-04-23 2020-10-20 The North Carolina Eye Bank, Inc Corneal graft assemblies for improved surgical operations
US11654048B2 (en) 2019-04-23 2023-05-23 Miracles In Sight DSAEK corneal graft assemblies for optimized surgical operations
US20230060227A1 (en) * 2021-09-01 2023-03-02 Tissuecor, Llc Device and system for injecting biological tissue

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DE102010051458B4 (de) 2010-11-17 2013-05-23 Geuder Ag Vorrichtung zum Bereitstellen und zum Einbringen eines Transplantats oder eines Implantats in den lebenden Körper, insbesondere für ophthalmologische Eingriffe und gebrauchsfertiges Set umfassend diese Vorrichtung.

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Publication number Priority date Publication date Assignee Title
US10481051B2 (en) 2016-10-13 2019-11-19 Lions VisionGift Corneal tissue sample assemblies and related methods of use

Also Published As

Publication number Publication date
PL2533724T3 (pl) 2016-11-30
DE102010051458A1 (de) 2012-05-24
DK2533724T3 (en) 2016-08-22
EP2533724B1 (fr) 2016-05-11
RS55066B1 (sr) 2016-12-30
PT2533724T (pt) 2016-08-18
WO2012065602A3 (fr) 2012-08-23
HRP20160972T1 (hr) 2016-10-07
ES2585634T3 (es) 2016-10-07
DE102010051458B4 (de) 2013-05-23
WO2012065602A2 (fr) 2012-05-24
DE202011106789U1 (de) 2011-11-15
HUE028091T2 (en) 2016-11-28

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